Study at a glance
An overview of the methodology and trial design of the ACT NoW study.
Aims
The aims of the ACT NoW Study are to determine the relative effectiveness and cost effectiveness of a Speech and Language Therapy (SLT) intervention for people with aphasia and/or dysarthria following stroke, when compared with an attention control. We also aim to explore the experience and the impact of the interventions from the perspective of both users and carers, using qualitative research.
The Trial Design
click the links in this section to see progress updates on each part of the trial
The ACT NoW study is a pragmatic, multi-centre randomised controlled trial (RCT) with a nested qualitative study and full economic evaluation. The RCT involves comparison of two arms within this target population: a manualised Speech and Language Therapy (SLT) intervention; and an 'attention control'. Randomisation will be stratified by diagnosis/severity as well as site/centre, with an 'intention to treat' approach.
The qualitative study will comprise interviews with patients and carers, purposefully sampled from each arm of the trial, to evaluate service user preferences for communication therapy after stroke. Innovative methods of communication support have been developed to enable people with communication difficulties to engage in the interview process.
The ACT NoW trial design was informed by a successful feasibility study. To find out more about this feasibility study, access the 'Preparing for the Main Study' web page.
Target Population
The target population for this study are people admitted to hospital post-stroke who have aphasia and/or dysarthria and are eligible for SLT. We aim to recruit a minimum of 170 patients to the trial: minimum of 85 in the intervention arm and 85 in the control arm.
Intervention
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Participants randomised into the treatment arm will receive early SLT of up to three sessions per week for a maximum duration of 16 weeks. The SLT intervention has been developed by a team of expert Speech and Language Therapists according to 'Best Practice Standards'. The intervention procedure is manualised to allow replicability by other Speech Therapy Departments if it is shown to be effective.
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Those in the attention control arm of the trial will receive a similar level of contact with a visitor who has no specific knowledge about communication therapy. They will provide empathy and spend time with the patient, without any input from Speech and Language Therapists.
Outcome Measurement
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Primary Outcome: as stipulated by the Health Technology Assessment Programme, the primary outcome for this study is participants' functional communication. This will be measured through a 'semi-structured conversation,' which will be videotaped and subsequently rated by independent expert Therapists. The raters will not know which intervention the patient has received in order to prevent bias.
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Secondary Outcomes: participants' own perception of their functional communication and quality of life will be assessed using a specially developed self-rated scale. This rating scale contains items such as, 'How well can you have a conversation with a person you know well?' to cover both understanding and expression in a range on communication situations and functional activities. This scale has been developed and extended for use in stroke trials and is now known as the Communication Outcome After Stroke (COAST) Scale*. An adapted version of this rating scale is used to assess carers' perception of the participants' functional communication and its effects on their own quality of life; carer 'well-being.'
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Health Economics Outcome: in addition the costs of communication therapy versus attention control will be compared.
All outcomes data will be collected 6 months after randomisation:
| Outcome | Measurement Methods |
| Participants' functional communication | Expert rating of semi structured conversation using the Therapy Outcomes Measures (TOMS) scale |
| Participants' perception of their functional communication and quality of life | The ACT NoW Rating Scale. This scale has been developed and extended for use in stroke trials and is now known as the Communication Outcome After Stroke (COAST) Scale* |
| Carers' perception of the participants' functional communication and its effects on carers' quality of life. | a carer-adapted version of the ACT NoW Rating Scale. As per above, this is also available for use in stroke trials and is known as the Carer COAST* |
| Carer 'well being' | Carers of Older People in Europe (COPE Index) |
| Participants' quality of life | EuroQuol (EQ-5D) |
| Health Economics - Costs of communication therapy versus attention control | Carers will self-complete the ACT NoW 'Support for Others Questionnaire' and research assistants will gather data for participant health economics evaluation through hospital records. |
*please see our resources page for copies of these scales and how they should be referenced
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